Financial Incentives for Smoking Cessation Among Mothers

Cigarette Smoking Clinical Trial

Official title:

Financial Incentives for Smoking Cessation Among Disadvantaged Mothers With Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05740098
• Other study ID #: 5R01HD078332
• Secondary ID: R01HD078332
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: October 2020

Study information

• Verified date: February 2023
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators will examine whether adding financial incentives and nicotine replacement dual therapy to current best practices for smoking cessation (i.e. referral to counseling using a telephone quit line) increases cessation rates in mothers and reduces second-hand smoke exposure in children. While perhaps more expensive upfront compared to best practices alone, the investigators hypothesize that this treatment approach will be a more cost-effective cessation intervention.

Description:

Smoking prevalence among disadvantaged mothers remains at strikingly high levels (40-60%). Disadvantaged women are more likely to begin smoking at an earlier age, be heavier smokers, be nicotine dependent, and fail in their efforts to quit smoking (Kandel et al., 2009). These women and their children also suffer higher rates of smoking-related adverse health consequences.

Despite widespread knowledge of the harmful effects of secondhand smoke exposure (SHSe), estimates are that 85% of children from low-income U.S. families experience chronic exposure. Children exposed to SHS are at increased risk for numerous serious health problems, including sudden infant death syndrome, more severe asthma, lower respiratory infections, and chronic middle ear disease, and maternal smoking is a particularly significant contributor to this increased morbidity and mortality. SHSe is also a substantial economic burden on the U.S. healthcare system, being estimated to increase direct medical and life-lost costs by > $5 billion annually.

Interventions developed to reduce children's SHSe have aimed to (1) decrease parental smoking around their children, (2) increase parental smoking cessation, or (3) both. Since smoking by a child's mother is a particularly significant contributor to SHSe, interventions have typically targeted smoking mothers. Regarding efforts to decrease smoking around children, studies testing relatively low-intensity interventions (e.g., written materials, brief advice) have failed to change exposure levels, while those testing more intensive interventions have had more success decreasing children's SHSe, with at least some instances of biochemically-verified changes.

Clearly, more effective smoking-cessation interventions for mothers are needed to meet the public health priority of reducing SHSe among children. The investigators recognize that maternal smoking cessation will not eliminate SHSe among children since many (~40%) live with more than one smoker. However, the evidence is clear that smoking mothers are the primary contributors to their children's SHSe, making them the obvious first target. The overarching goal of this project is to develop an efficacious, cost-effective incentive-based smoking cessation intervention that is combined with state-of-the-art smoking-cessation pharmacotherapy practices to optimize outcomes.

Participants will be 250 mothers (10 pilot and 80 per treatment condition) recruited from our university-affiliated hospital's pediatric practice, other pediatric and family medicine practices throughout the county in which our clinic is located, local offices for Women, Infants, and Children (WIC), and other recruitment strategies (e.g., ads on Facebook). Participants will be randomly assigned to one of three treatment conditions: (1) usual care for smoking cessation and protecting children from SHSe, (2) usual care combined with incentives for objectively verified smoking abstinence, and (3) usual care combined with incentives and pharmacotherapy using innovative procedures to enhance its efficacy.

The investigators believe combining pharmacotherapies with incentives could be an effective strategy for surmounting adherence problems in this population by assuring that women have regular contact with clinic staff and thereby providing staff opportunities to problem-solve obstacles that may have arisen around adherence or side effects and to regularly underscore the importance and potential benefits of using the medications as prescribed.

The investigators hypothesize that each of the interventions with incentives will increase smoking abstinence compared to usual care alone, but that the largest magnitude and most cost-effective treatment effects will be achieved by combining incentives with pharmacotherapy. They also hypothesize that (a) both incentives interventions will decrease child cotinine levels significantly more than usual care alone and (b) that SHSe levels will be significantly lower among children of abstainers than smokers.

Taken together, developing efficacious and cost-effective interventions to increase smoking cessation interventions among disadvantaged mothers and reducing SHSe among their children is an important U.S. public health priority. The financial incentives model is effective with other treatment-recalcitrant populations and we believe has the potential to meet this important public-health challenge. Behavioral-economic theory suggests that the efficacy of the cessation intervention is at least in part attributable to providing smaller, more immediate incentives for success that act to bridge the temporal delay to the larger naturalistic rewards of improved health outcomes for mother and child. The investigators will continue to investigate the behavioral-economic processes involved in smoking among disadvantaged women and in individual differences in treatment response. Lastly, there is rapidly growing interest in the use of incentives to promote healthy behavior change in disadvantaged populations. The proposed project and others like it will be important to assuring that the necessary scientific knowledge is available to support that effort.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: October 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Expresses interest in quitting smoking

• Express willingness to initiate NRT

• Mother is = 18 years of age

• Self-reported smoking = 10 cigarettes per day for = 1 year, biochemically verified

• Mother has a child < 12 years of age

• Child resides with mother full-time

• Not currently using any other tobacco cessation medications (e.g. Chantix) or NRT, or willing to stop use prior to participation in the study

• Lives in Chittenden County, Vermont or surrounding counties

• Plans on remaining in the geographical area for the next 12 months

• English-speaking

• Willing to let child participate in the study

Exclusion Criteria:

• Failing to meet any of the above criteria

• Has medical contraindications to NRT products

• Meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for moderate or severe alcohol or drug dependence other than nicotine in the prior 12 months (those on opioid substitution therapy are allowed)

• Current/past psychotic disorder

• Being suicidal

• Currently pregnant or trying to become pregnant in the next 12 months

• Incarceration

• Refusal to participate in study

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• Best Practices
Five As plus referral to a quit line
• Financial Incentives
Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.

Drug:
• Nicotine Replacement Therapy
Nicotine patches and gum/lozenge provided together for dual therapy

Locations

Country	Name	City	State
United States	University of Vermont Medical Center	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Outpatient Child Visits to Healthcare Center.	Number of outpatient child visits will be compared between the three treatment arms and between abstainers versus smokers, independent of treatment condition.	48 weeks following quit date.
Other	Number of Inpatient Child Visits to Healthcare Center.	Number of inpatient child visits will be compared between the three treatment arms and between abstainers versus smokers, independent of treatment condition.	48 weeks following quit date.
Other	Number of Times Child Received Prescription Medications.	Number of times child received prescription medications will be compared between the three treatment arms and between abstainers versus smokers, independent of treatment condition.	48 weeks following quit date.
Other	Cost-effectiveness Analysis	Cost-effectiveness will include the cost of each intervention, measured by the Brief Drug Abuse Treatment Cost Analysis Program (Brief-DATCAP) and the economic cost of treatment (fixed costs based upon proportion of time and/or space utilized by the program). Estimated treatment costs will be combined with estimated child healthcare utilization costs to represent total costs per treatment condition. Treatment costs will be compared across the three treatment arms.	Study entry through 48 weeks following quit date.
Primary	7-day Point Prevalence Smoking Abstinence Levels	Point prevalence abstinence will be defined as self-report of no smoking in the past 7 days, not even a puff, with biochemical verification via breath carbon monoxide (CO) and urine cotinine. Abstinence at the 12-week (end of treatment) and 24-week assessment will be compared between the three treatment arms.	Collected once per woman at approximately 12- and 24- weeks following quit date in each of the three smoking arms
Primary	Objective Measure of Child Secondhand Smoke Exposure (SHSe)	SHSe will be defined as the level of cotinine measured in the urine of the youngest child at baseline, 6-, 12-, and 24-weeks following the mother's quit date. SHSe outcomes will be compared between the three treatment arms and between children of abstainers versus smokers independent of treatment condition. We hypothesize being able to detect greater reductions from baseline levels in the incentives compared to Best Practices treatment conditions and among abstainers compared to smokers. We report main effects of treatment condition as geometric means (+/- SEM) collapsed across the three assessment times for each treatment condition controlling for baseline values.	Collected twice per child at baseline, and once at approximately 6-, 12- and 24-weeks following quit date
Secondary	Continuous Abstinence	Continuous abstinence will be defined as self-report of no smoking in the past 7 days at each time point, not even a puff, with biochemical verification via breath CO and urine cotinine. Continuous abstinence from quit date through 24 week assessment will be compared between the three treatment arms.	24 weeks following quit date
Secondary	7-day Point Prevalence Abstinence at 48-week Follow-up Assessment	Point prevalence abstinence will be defined as self-report of no smoking in the past 7 days, not even a puff, with biochemical verification via breath CO and urine cotinine. We will use this data to estimate relapse rates across treatment arms and for use in comparing SHSe levels in children of abstainers versus smokers.	48 weeks following quit date
Secondary	Smoking Abstinence	Biochemically-verified 7-day point-prevalence smoking abstinence.	Assessed once per woman at 6-, 12-, 24-, and 48-weeks following quit date.
Secondary	Smoking Abstinence	Biochemically-verified 7-day point-prevalence smoking abstinence.	Collected once per woman at baseline, 6-, 12-, 24-, and 48-weeks following quit date.